Daily Rules, Proposed Rules, and Notices of the Federal Government
We published the regulation, “Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed,” (21 CFR 589.2000) in the
On October 30, 2001, we held a public hearing in Kansas City, MO to hear views from the public on the adequacy of the present BSE feed regulation. We specifically invited comments, both oral and written, on 17 questions about ways the rule and its enforcement might be improved to achieve its original objectives of preventing the establishment and amplification of BSE in the United States. We appreciate the efforts of the many organizations and individuals who took the time to express the views of various segments of the animal feed industry, regulatory agencies, concerned consumers, and consumer organizations on the adequacy of the present feed rule.
Shortly after the public hearing, the U.S. Department of Agriculture (USDA) released a report prepared by the Harvard Center for Risk Analysis (
USDA's BSE surveillance program supports the findings of the Harvard study that measures implemented by the U.S. Government, such as early import restrictions and the feed ban, have been effective in preventing the entrance and establishment of BSE in the U.S. cattle population. The USDA surveillance program, which has been in place since May 1990 and which targets the highest risk cattle population, has found no cases of BSE to date. Although BSE has not been detected in the United States, the U.S. Government's response to BSE has always been proactive and preventive. Therefore, USDA and FDA are interested in exploring measures that could further reduce the already small risk that BSE will enter and become established in the United States. To that end, FDA is once again asking for information from the affected industries and the public on several ways that the animal feed regulation could be strengthened.
We are soliciting information and comments from those with interest and expertise in any of the following five aspects of the BSE feed regulation:
The Harvard risk assessment identified removal of high risk tissues, such as brain, spinal cord, gut, and eyes, from human food and rendered material for animal feed, as a way to dramatically reduce the potential exposure of cattle and humans to the BSE agent. In response to the Harvard study, USDA's Food Safety Inspection Service is considering rulemaking to ban high risk tissues obtained from certain populations of cattle (also called specified risk materials or SRMs) from use in human food. Should USDA publish such a proposal, FDA may also propose that SRMs be prohibited from going into rendered material. Therefore, FDA is asking for comments on the following questions:
• Should high risk materials, such as brain and spinal cord from ruminants 2 years of age and older, be excluded from all rendered products?
• How feasible would it be for the rendering industry to implement such an exclusion?
• What will be the adverse and positive impacts (economic, environmental, health, etc.) resulting from a brain and spinal cord exclusion?
In some parts of the country where cattle are raised in proximity to large poultry production areas, poultry litter, composed of excreta, bedding, spilled feed, and feathers, may be used as a feed ingredient for cattle. The Harvard risk assessment said that the risk from the use of poultry litter as a feed supplement should be investigated
• How extensive is the use of poultry litter in cattle feed in the United States?
• What is the level of feed spillage in poultry litter?
• What are the methods used to process poultry litter before inclusion in animal feed?
• What will be the adverse and positive impacts (economic, environmental, health, etc.) resulting from banning poultry litter in ruminant feed?
Under the current regulation, pet food for retail sale is exempt from the labeling requirement and need not bear the caution statement “Do not feed to cattle or other ruminants.” However, if the pet food products are sold or are intended for sale as distressed or salvage items, then, under § 589.2000(d)(4), such products must state, “Do not feed to cattle or other ruminants.” In order to assure that salvaged pet food is not used in ruminant feed despite the requirement that it be labeled with the caution statement, FDA is asking for comments on the following questions.
• Should pet food for retail sale be labeled with the statement “Do not feed to cattle or other ruminants.”?
• What would be the adverse and positive impacts (economic, environmental, health, etc.) of such a labeling requirement?
The Harvard risk assessment and the FDA public hearing identified cross-contamination of feed and facilities as a possible BSE risk. The current animal feed regulation permits feed and feed ingredients for ruminant animals to be processed in facilities that also process prohibited proteins. The rule requires that those firms handling both prohibited and nonprohibited material have a system in place and a written plan to prevent cross-contamination. We provided suggestions in the preamble to the final rule and in the small entity compliance guides on ways to prevent carry-over in shared equipment. Small entity compliance guides include: No. 67—Renderers; No. 68—Protein Blenders, Feed Manufacturers, and Distributors; No. 69—Feeders of Ruminant Animals With On-Farm Feed Mixing Operations; No. 70—Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations; and No. 76—Questions and Answers, BSE Feed Regulation. You may see the small entity compliance guides on the Center for Veterinary Medicine (CVM) Internet site at
The rule requires that those firms handling both prohibited and nonprohibited material have a system in place and a written plan to prevent cross-contamination. The only way to be sure that there is absolutely no potential for carry-over of, or cross-contamination with, prohibited material is to use completely separate facilities. We are interested in information on control measures, other than dedicated facilities, that apply specifically to transmissible spongiform encephalopathy (TSE) agents and in information on whether such measures can prevent carry-over of prohibited material. The agency is asking for comments on the following questions:
• Are there practical ways, other than dedicated facilities, for firms to demonstrate that the level of carry-over could not transmit BSE to cattle or other ruminants? If so, what is the safe level of carry-over in a feed mill; and
• What is the scientific rationale used to establish this safe level?
• What steps are firms currently taking to prevent cross-contamination of prohibited protein into ruminant feed, and what are the costs of those steps?
The current regulation contains an exemption that permits “inspected meat products which have been cooked and offered for human food and further heat processed for feed (such as plate waste and used cellulosic food casings)” to be fed to ruminants. Although the Harvard study concluded that plate waste posed a minimal risk, FDA wishes to reconsider this exemption and is seeking information on the following questions.
• To what extent is plate waste used in ruminant feed?
• What is the composition of plate waste, and what are its sources?
• How is plate waste processed before inclusion in ruminant feed?
• What would be the adverse and positive impacts (economic, environmental, health, etc.) from excluding plate waste from ruminant feed?
You may submit written or electronic comments regarding the advance notice of proposed rulemaking (ANPRM) by February 4, 2003, to the Dockets Management Branch (see
You may submit comments electronically on the Internet at:
This ANPRM is issued under sections 201, 402, 409, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 348, and 371) and under the authority of the Commissioner of Food and Drugs.